FDA urged to protect consumers from illegal sales of tianeptine

Unapproved antidepressant drug, which stimulates opioid receptors, is widely available as dietary supplement in southern U.S.

An unapproved and addictive drug is commonly available for sale in gas stations, vape stores, and other retail outlets in the South, notably in Alabama, and online. The Center for Science in the Public Interest says the Food and Drug Administration should take further enforcement action against manufacturers, distributors, and retailers that sell tianeptine—a drug approved in some countries, though not in the United States, as an antidepressant, but illegally sold here as if it were a dietary supplement.

Both the FDA and the Centers for Disease Control and Prevention have issued warnings to companies and consumers of the dangers of tianeptine. Both agencies warned consumers that tianeptine, which stimulates opioid receptors, may trigger addiction and withdrawal symptoms in consumers. The FDA in 2018 sent warning letters to manufacturers informing them that supplements containing tianeptine are illegal, as are any claims that the pills treat opioid withdrawal or any other condition. The products have never been FDA-approved for those indications. Yet these products, with names such as Tianaa Red, Tianaa White, Tianaa Green, Za Za Red, and Za Za Silver remain on the market.

Brandon Lackey, the chairperson of the Alabama Association of Christian Recovery Ministries, sent CSPI images of tianeptine-containing pills for sale at retail locations in his state, including BP, Shell, Chevron, and SAMCO gas stations. He’s been pushing for a statewide prohibition on tianeptine through the Alabama legislature and is joining CSPI’s request to the FDA to do more to protect consumers.

“The continued widespread availability of this unapproved and addictive drug at retail locations in Alabama is proof positive that the FDA’s warnings have not been sufficient to protect consumers from these products,” Lackey said. “It’s especially cruel to give consumers the impression that these products help with addiction or withdrawal symptoms when in fact they may cause addiction or withdrawal.”

The CDC reports an uptick in calls to poison control centers related to tianeptine, from 5 calls in 2014 to 81 calls in 2017, and the FDA’s adverse event reporting systems have collected more than 470 reports, including 55 reports involving death.

One online retailer, jackbgoods.com, was the subject of one of the FDA’s 2018 warning letters for marketing tianeptine supplements under the TIANAA brand alongside statements indicating that the product could replace kratom, another unapproved substance which affects brain opioid receptors, in offering “an unparalleled solution to cravings for opiates” and “a clear choice for pain and anxiety.” Yet as of late July, the company still sold tianeptine, but under the Za Za brand, alongside claims such as “Increase Alertness/Focus” and “Feel Good-Be Happy.” Za Za’s distributors have been variously listed on labels as MT Distributions, MT Brands, and M&J Brands of Cape Coral, FL.

“The handful of companies involved in distributing tianeptine try to fly just beneath the radar and escape the scrutiny of regulators,” said CSPI policy director Laura MacCleery. “But by ignoring the FDA’s warnings, the companies are putting vulnerable consumers who may be dealing with a life-threatening addiction at risk.”

CSPI’s letter to FDA Commissioner Stephen Hahn and other FDA officials urges the agency to work cooperatively with state, federal, and local officials to remove the products from the market.

“These companies are preying on an especially vulnerable population of people who are either abusing opioid drugs, or who are trying to overcome opioid addiction,” said CSPI president Dr. Peter G. Lurie, who led an inter-agency working group on prescription drug abuse while at the FDA. “That should make it a high enforcement priority for the agency.”